Date:
May 6, 2026
Content:
The U.S. Food and Drug Administration (FDA) has published a Form 483 detailing inspection observations for Somerset Therapeutics Private Limited, a pharmaceutical manufacturing facility based in India. The document reflects findings from an agency inspection that concluded in February 2025.
An FDA Form 483 is issued when investigators identify conditions that may constitute violations of the Food, Drug, and Cosmetic Act. These observations typically focus on deficiencies in Current Good Manufacturing Practices (cGMP), ranging from equipment maintenance and sanitation to laboratory controls and documentation procedures.
Following the issuance of this report, the company is required to review the findings and provide a formal response to the FDA. This response must outline specific corrective actions Somerset Therapeutics intends to take to resolve the identified issues and ensure the safety and quality of their drug products.
Source: FDA CDER FOIA Electronic Reading Room
Link:
http://www.fda.gov/drugs/cder-foia-electronic-reading-room/somerset-therapeutics-private-limited-02212025
Keywords:
FDA, Form 483, Somerset Therapeutics, India, Drug Manufacturing, Pharmaceutical Inspection, cGMP